According to the American Diabetes Association, diabetes mellitus, or simply, diabetes, is a group of diseases characterized by high blood glucose levels that result from defects in the body's ability to produce and/or use insulin. Type 1 diabetes is usually diagnosed in children and young adults, and was previously known as juvenile diabetes. In type 1 diabetes, the body does not produce insulin. Type 2 diabetes is the most common form of diabetes. In type 2 diabetes, either the body does not produce enough insulin or the cells ignore the insulin. During pregnancy—usually around the 24th week—many women develop gestational diabetes. A diagnosis of gestational diabetes doesn't mean that you had diabetes before you conceived, or that you will have diabetes after giving birth.
Diabetes is managed primarily by controlling the level of glucose in the bloodstream. This level is dynamic and complex, and it is affected by multiple factors including the amount and type of food consumed and the amount of insulin (which mediates transport of glucose across cell membranes) in the blood. BG levels are also sensitive to exercise, sleep, stress, smoking, travel, illness, menses, and other psychological and lifestyle factors unique to individual patients. The dynamic nature of BG, insulin, and all other factors affecting BG often require a person with diabetes to forecast BG levels. Therefore, therapy in the form of insulin, oral medications, or both, can be timed to maintain BG levels in an appropriate range.
Management of diabetes is time-consuming for patients because of the need to consistently obtain reliable diagnostic information, follow prescribed therapy, and manage lifestyle on a daily basis. Diagnostic information, such as BG level, is typically measured with a handheld BG meter using a capillary blood sample obtained with a lancing device. Interstitial glucose levels may be obtained from a continuous glucose sensor worn on the body. Prescribed therapies may include insulin, oral medications, or both. Insulin can be delivered with a syringe, an ambulatory infusion pump, or a combination of both. With insulin therapy, determining the amount of insulin to be injected can require forecasting of meal composition (fats, carbohydrates, and proteins) and the effects of exercise or other physiological states. The management of lifestyle factors such as body weight, diet, and exercise can significantly influence the type and effectiveness of a therapy.
Management of diabetes involves large amounts of diagnostic data and prescriptive data acquired in a variety of ways: from medical devices, from personal healthcare devices, from patient-recorded logs, from laboratory tests, and from healthcare-professional recommendations. Medical devices include patient-owned BG meters, continuous glucose monitors, ambulatory insulin-infusion pumps, diabetes-analysis software, and diabetes-device configuration software. Each of these systems generates and/or manages large amounts of diagnostic and prescriptive data. Personal healthcare devices include weight scales, blood-pressure cuffs, exercise machines, thermometers, and weight-management software. Patient-recorded logs include information relating to meals, exercise, and lifestyle. Lab test results include HbA1C, cholesterol, triglycerides, and glucose tolerance. Healthcare-professional recommendations include prescriptions, diets, test plans, therapy changes and other information relating to the patient's treatment.
Patients with diabetes and their healthcare professionals interact with a variety of medical devices and systems to help manage the disease. For each of these differing types of medical devices, there is a need to aggregate, manipulate, manage, present, and communicate diagnostic data and prescriptive data from multiple data sources in an efficient manner to improve the care and health of a person with diabetes, so the person with diabetes can lead a full life and reduce the risk of complications from diabetes. There is also a need to aggregate, manipulate, manage, present, and communicate such diagnostic data and prescriptive data amongst the different types of medical devices using a standard communication protocol. Continua® Health Alliance (“Continua”) is a trade association working toward establishing such a protocol via systems and standards for interoperable medical devices. Design guidelines put forth by Continua leverage various IEEE standards, including IEEE 11073, which pertains to the interoperability of personal healthcare devices. Safety is of concern when different health devices interact with one another because unexpected interfacing problems can occur. Standard protocols lead to predictable outcomes and make it possible for patients to rely on such a diabetes manager.
The background description provided herein is for the purpose of generally presenting the context of the disclosure. Work of the presently named inventors, to the extent it is described in this background section, as well as aspects of the description that may not otherwise qualify as prior art at the time of filing, are neither expressly nor impliedly admitted as prior art against the present disclosure.